A Phase 1/2 interventional study of SAR161271 and Insulin glargine HOE901 in Type 1 Diabetes Mellitus, sponsored by Sanofi. Completed at 1 site in Germany. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-07-26.
Sponsored by Sanofi · Phase 1/2, Interventional, and Treatment
Primary Objective:
- To establish initial safety/tolerability and pharmacodynamic and pharmacokinetic profiles of four formulations of SAR161271 in patients with T1DM.
Secondary Objective:
- To establish relative potency of SAR161271 compared with insulin glargine in patients with T1DM
The total per patient is between 31 and 67 days; including post-study visit between 108 and 172 days. In case of an additional late post-study visit after last dosing, approximately 213 to 279 days, broken down as follows:
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's enrollment of 46 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.
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Cross-over design of four formulation of SAR161271 0.3U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
Drug: SAR161271 · Drug: Insulin glargine HOE901
Cross-over design of four formulation of SAR161271 0.6U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
Drug: SAR161271 · Drug: Insulin glargine HOE901
Cross-over design of four formulation of SAR161271 1.2 U/kg or insulin glargine administered as a single dose in the morning between about 11h00 and about 12h00; fasting for about 12h before and for the duration of the clamp
Drug: SAR161271 · Drug: Insulin glargine HOE901
Pharmaceutical form:Solution for injection Route of administration: subcutaneous
Pharmaceutical form:Solution for injection Route of administration: subcutaneous
- Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each cohort
Time frame: up to 7 days after dose
- Pharmacodynamics (Glucose infusion rate) time-action profile
Time frame: up to 30 hours after dose
- Pharmacokinetic parameters
Time frame: up to 168 hours after dose
- anti-insulin antibody production
Time frame: pre-dose and after 4th dose
The record gives a start of Feb 2010, a primary completion of May 2010 and a completion of Nov 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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